Template Information
As9100d:2016
Category: manufacturing
Template Questions
- 4.1 Understanding the organization and its context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the quality management system
- 4.4 Quality management system and its processes
- 5.1 Leadership and commitment
- 5.2 Policy
- 5.3 Organizational roles, responsibilities and authorities
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
- 7.1 Resources
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented information
- 8.1 Operational planning and control
- Consider the following:1. personal/product safety2. producibility and inspectability3. reliability, a
- Consider the following:1. design verification2. process control - selection and verification of key c
- Quality plan can be the documented information showing the QMS processes and the resources to be appl
- 8.1.1 Operational Risk Management
- 8.1.2 Configuration Management
- 8.1.3 Product Safety
- Potential examples could include:1. assessment of hazards and management of associated risks.2. manag
- 8.1.4 Prevention of Counterfeit Parts
- Counterfeit part prevention processes should consider:1. training of appropriate persons in the aware
- 8.2 Determination of requirements for products and services
- 8.3 Design and development of products and services
- 8.3.2 Design and development planning
- 8.3.3 Design and development inputs
- 8.3.4 Design and development controls
- 8.3.5 Design and development outputs
- Data can include:1. drawings, part lists and specifications necessary to define the configuration and
- 8.3.6 Design and development changes
- 8.4.1 General
- 8.4.2 Type and extent of control
- Verification activities can include:1. review of objective evidence from the external provider.2. ins
- 8.4.3 Information for external providers
- 8.5.1 Control of production and service provision
- 1. Documented information that defines characteristics of products and services can include digital p
- 8.5.1.1 Control of Equipment, Tools and Software Programs
- 8.5.1.2 Validation and Control of Special Processes
- 8.5.1.3 Production Process Verification
- These activities can include risk assessments, capacity studies, capability studies and control plans
- 8.5.2 Identification and traceability
- Traceability requirements can include:1. Identification to be maintained throughout the product life2
- 8.5.3 Property belonging to customers or external providers
- 8.5.4 Preservation
- 8.5.5 Post-delivery activities
- 8.5.6 Control of changes
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
- 9.1 Monitoring, measurement, analysis and evaluation
- 9.2 Internal audit
- 9.3 Management review
- 10.1 General
- 10.2 Nonconformity and corrective action
- 10.3 Continual improvement
- Examples of continual improvement opportunities can include lessons learned, problem resolutions and